VK-2019 for Lymphoma

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Thomas Jefferson University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase Ib in adult patients with relapsed or refractory EBV-positive DLBCL using daily oral dosing of VK-2019 in three dose escalation cohorts: 600 mg/day, 1200 mg/day, 1800 mg/day for 28 days (cycle), until progression or toxicity.

Research Team

Eligibility Criteria

This trial is for adults with EBV-positive DLBCL, a type of lymphoma, who have tried other treatments that didn't work. Participants will take an oral medication daily in increasing doses to find the right balance between effectiveness and safety.

Inclusion Criteria

4.1 Inclusion Criteria

1. Informed consent obtained prior to any protocol mandated assessment.

2. Age ≥ 18 years.

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Treatment Details

Interventions

VK-2019 (Virus Therapy)

Trial OverviewVK-2019 is being tested at three different strengths (600 mg, 1200 mg, and 1800 mg) taken once a day for cycles of 28 days. The goal is to see how well it works and what dose is best for people whose lymphoma has come back or hasn't responded to treatment.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Treatment (VK-2019 Dose 600mg)Experimental Treatment1 Intervention

Dose cohort A will dose at 600mg. VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort A will dose at 600 mg dose. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.

Group II: Treatment (VK-2019 Dose 1800mg)Experimental Treatment1 Intervention

Dose cohort C will dose at 1800mg. VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort C will dose at 1800 mg dose. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.

Group III: Treatment (VK-2019 Dose 1200mg)Experimental Treatment1 Intervention

Dose cohort B will dose at 1200mg.VK-2019 will be administered daily starting on day 1 of cycle 1 (D1C1). Dose cohort B will dose at 1200 mg dose. Treatment cycles will repeat every 28 days , in the absence of disease progression or unacceptable toxicity.